Publications by authors named "Nitin Mehrotra"

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Platform Assessment of Concentration-QTc Relationship Across GalNAc-siRNA Molecules.
Prajakta Badri, Kiranmai Kolachana, Anh Duong, Maxwell Lasko, Tirtha Nandi, Nitin Mehrotra

Clin Pharmacokinet· December 2025

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Driving Efficiency: Leveraging Model-Informed Approaches in 505(b)(2) Regulatory Actions.
Vishnu Dutt Sharma, Venkatesh Atul Bhattaram, Kevin Krudys, Zhihua Li, Anshu Marathe, Nitin Mehrotra

J Clin Pharmacol· December 2024

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Replicate Testing of Clinical Endpoints Can Prevent No-Go Decisions for Beneficial Vaccines.
Daniel I S Rosenbloom, Julie Dudášová, Casey Davis, Radha A Railkar, Nitin Mehrotra

Vaccines (Basel)· September 2023

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Identifying and characterising sources of variability in digital outcome measures in Parkinson's disease.
George Roussos, Teresa Ruiz Herrero, Derek L Hill, Ariel V Dowling, Martijn L T M Müller, Nitin Mehrotra

NPJ Digit Med· July 2022

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Neurodegenerative Diseases: The Value of Early Predictive End Points.
Sarah Janicki Hsieh, Zoi Alexopoulou, Nitin Mehrotra, Arie Struyk, S Aubrey Stoch

Clin Pharmacol Ther· April 2022

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Minimal brain PBPK model to support the preclinical and clinical development of antibody therapeutics for CNS diseases.
Peter Bloomingdale, Suruchi Bakshi, Christian Maass, Eline van Maanen, Cesar Pichardo-Almarza, Nitin Mehrotra

J Pharmacokinet Pharmacodyn· December 2021

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A Disease Progression Model to Quantify the Nonmotor Symptoms of Parkinson's Disease in Participants With Leucine-Rich Repeat Kinase 2 Mutation.
Malidi Ahamadi, Nitin Mehrotra, Nathan Hanan, Ka Lai Yee, Ferdous Gheyas

Clin Pharmacol Ther· August 2021

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Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science.
Diane Stephenson, Robert Alexander, Varun Aggarwal, Reham Badawy, Lisa Bain, Nitin Mehrotra

Digit Biomark· November 2020

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Extrapolation of Adult Efficacy to Pediatric Patients With Chemotherapy-Induced Nausea and Vomiting.
Jeremiah D Momper, M Tobias Heinrichs, Kevin Krudys, Donna Griebel, Shaun Kumar, Nitin Mehrotra

J Clin Pharmacol· June 2020

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Use of a Systems Pharmacology Model Based Approach Toward Dose Optimization of Parathyroid Hormone Therapy in Hypoparathyroidism.
Manoj Khurana, Immo Zadezensky, Naomi Lowy, Dragos Roman, Jean-Marc Guettier, Nitin Mehrotra

Clin Pharmacol Ther· March 2019

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PDUFA VI: It Is Time to Unleash the Full Potential of Model-Informed Drug Development.
Lokesh Jain, Nitin Mehrotra, Larissa Wenning, Vikram Sinha

CPT Pharmacometrics Syst Pharmacol· January 2019

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Quantitative Understanding of QTc Prolongation and Gender as Risk Factors for Torsade de Pointes.
Lars Johannesen, Christine Garnett, Man Luo, Shari Targum, Jens Stampe Sørensen, Nitin Mehrotra

Clin Pharmacol Ther· February 2018

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Use of statistical and pharmacokinetic-pharmacodynamic modeling and simulation to improve decision-making: A section summary report of the trends and innovations in clinical trial statistics conference.
Holly Kimko, Seth Berry, Michael O'Kelly, Nitin Mehrotra, Matthew Hutmacher

J Biopharm Stat· January 2018

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Esomeprazole FDA Approval in Children With GERD: Exposure-Matching and Exposure-Response.
Justin C Earp, Nitin Mehrotra, Kristina E Peters, Robert P Fiorentino, Donna Griebel

J Pediatr Gastroenterol Nutr· September 2017

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Enrolling Adolescents in Disease/Target-Appropriate Adult Oncology Clinical Trials of Investigational Agents.
Meredith K Chuk, Yeruk Mulugeta, Michelle Roth-Cline, Nitin Mehrotra, Gregory H Reaman

Clin Cancer Res· January 2017

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Exposure-Response of Palonosetron for Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients.
Jian Wang, Nitin Mehrotra, Insook Kim, Sue-Chih Lee, Farrokh Sohrabi

J Pediatr Gastroenterol Nutr· October 2016

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Utility of Exposure-Response Analysis in Regulatory Decision on the Selection of Starting Dose of Pasireotide for Cushing Disease.
Jingyu Yu, Sang Chung, Immo Zadezensky, Ke Hu, Christelle Darstein, Nitin Mehrotra

J Clin Pharmacol· August 2016

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Role of Quantitative Clinical Pharmacology in Pediatric Approval and Labeling.
Nitin Mehrotra, Atul Bhattaram, Justin C Earp, Jeffry Florian, Kevin Krudys

Drug Metab Dispos· July 2016

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Rendering the 3 + 3 Design to Rest: More Efficient Approaches to Oncology Dose-Finding Trials in the Era of Targeted Therapy.
Lei Nie, Eric H Rubin, Nitin Mehrotra, José Pinheiro, Laura L Fernandes

Clin Cancer Res· June 2016

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FDA Approval: Blinatumomab.
Donna Przepiorka, Chia-Wen Ko, Albert Deisseroth, Carolyn L Yancey, Reyes Candau-Chacon, Nitin Mehrotra

Clin Cancer Res· September 2015

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Reporting guidelines for population pharmacokinetic analyses.
Kevin Dykstra, Nitin Mehrotra, Christoffer Wenzel Tornøe, Helen Kastrissios, Bela Patel

J Clin Pharmacol· August 2015

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Considerations for assessing the potential effects of antidiabetes drugs on cardiac ventricular repolarization: A report from the Cardiac Safety Research Consortium.
Simon Heller, Börje Darpö, Malcolm I Mitchell, Helle Linnebjerg, Derek J Leishman, Nitin Mehrotra

Am Heart J· July 2015

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On the formation of SFn (-) (n = 1-6) anions via a novel route and their properties.
Rupali Mane, Nitin Mehrotra, Dilip K Maity, Anit K Gupta

Rapid Commun Mass Spectrom· July 2015

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FDA Approval: Belinostat for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma.
Hyon-Zu Lee, Virginia E Kwitkowski, Pedro L Del Valle, M Stacey Ricci, Haleh Saber, Nitin Mehrotra

Clin Cancer Res· June 2015

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Reporting guidelines for population pharmacokinetic analyses.
Kevin Dykstra, Nitin Mehrotra, Christoffer Wenzel Tornøe, Helen Kastrissios, Bela Patel

J Pharmacokinet Pharmacodyn· June 2015

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